AZD1419 / AstraZeneca, Dynavax - LARVOL DELTA

[VIRTUAL] Predictors of loss of asthma control in the Phase 2a INCONTRO trial: A post-hoc analysis (ERS 2020) - P2 | "The primary endpoint of the trial – the effect of the TLR9 agonist AZD1419 on the time to loss of asthma control (LOC) – was not met... Established markers of type 2 inflammation were associated to risk of LOC following withdrawal of standard asthma therapy and longitudinal changes in FeNO preceded LOC. Elevated markers of systemic inflammation were inversely associated to the risk of LOC."

P2a data • Retrospective data • Asthma • Immunology • Respiratory Diseases • ALK

A Phase 2a, Double-Blind, Placebo-Controlled Randomized Trial of Inhaled TLR9 Agonist AZD1419 in Asthma. (PubMed, Am J Respir Crit Care Med) - P2 | "AZD1419 was safe and well-tolerated but did not lead to improved asthma control, despite reducing markers of type 2 inflammation. Results suggest that a novel accelerated step-down approach based on FeNO is possible for well controlled asthma patients. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT02898662."

Clinical • Journal • P2a data • Asthma • Immunology • Respiratory Diseases

Dynavax and AstraZeneca to advance TLR9 agonist for treatment of asthma into phase 2a clinical study (Digital Journal) - "Dynavax Technologies...announced that the Company and AstraZeneca...signed an amendment to the existing Research Collaboration and License Agreement under which AstraZeneca will fully fund and Dynavax will conduct a Phase 2a safety and efficacy trial of AZD1419 in patients with asthma."

Anticipated new P2a trial • Anticipated phase shift • Licensing / partnership • Asthma

First-in-human study with the inhaled TLR9 oligonucleotide agonist AZD1419 results in interferon responses in the lung, and is safe and well-tolerated. (PubMed, Clin Pharmacol Ther) - "No evidence of tolerisation or amplification of responses was evident on repeated dosing and 15.4 mg was defined as maximum tolerated dose. AZD1419 clinical data supports its continued development as a potentially disease-modifying therapeutic in asthma."

Journal • P1 data

A Phase 2a Randomized, Double-Blind, Placebo-Controlled Trial with Withdrawal Design of AZD1419, a Toll-9 Agonist in Adults with Eosinophilic, Moderate to Severe Asthma (ATS 2019) - "AZD1419 was safe, well-tolerated and induced an interferon response but did not lead to improved asthma control by modification of the Th2 immunity response."

Clinical • IO Biomarker • P2a data